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申请号 | 产品号 | 商品名 | 活性成分 | 活性成分 | 剂型/给药途径 | 规格/剂量 | 申请机构 | 批准时间 | 参比制剂 | 标准制剂 | 市场状态 | TE |
---|---|---|---|---|---|---|---|---|---|---|---|---|
(ANDA) 218628 | 003 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 盐酸丁螺环酮 | CAPSULE;ORAL | 15MG | EPIC PHARMA LLC | 2025-03-13 | No | No | RX | |
(ANDA) 218628 | 001 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 盐酸丁螺环酮 | CAPSULE;ORAL | 7.5MG | EPIC PHARMA LLC | 2025-03-13 | No | No | RX | |
(ANDA) 218628 | 002 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 盐酸丁螺环酮 | CAPSULE;ORAL | 10MG | EPIC PHARMA LLC | 2025-03-13 | No | No | RX | |
(ANDA) 218773 | 001 | TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 曲安奈德 | INJECTABLE;INJECTION | 10MG/ML | DR REDDYS | 2025-03-12 | No | No | RX | AB |
(ANDA) 218386 | 001 | ALBUTEROL SULFATE | ALBUTEROL SULFATE | 硫酸沙丁胺醇 | SOLUTION;INHALATION | EQ 0.5% BASE | RITEDOSE CORP | 2025-03-12 | No | No | RX | AN |
(ANDA) 216125 | 001 | FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 氟[18F]脱氧葡糖 | INJECTABLE;INTRAVENOUS | 20-400mCi/ML | BAMF | 2025-03-11 | No | No | RX | AP |
(ANDA) 218271 | 002 | EPHEDRINE SULFATE | EPHEDRINE SULFATE | 硫酸麻黄碱 | SOLUTION;INTRAVENOUS | 50MG/10ML (5MG/ML) | FRESENIUS KABI USA | 2025-03-11 | No | No | RX | AP |
(ANDA) 218271 | 001 | EPHEDRINE SULFATE | EPHEDRINE SULFATE | 硫酸麻黄碱 | SOLUTION;INTRAVENOUS | 25MG/5ML (5MG/ML) | FRESENIUS KABI USA | 2025-03-11 | No | No | RX | AP |
(ANDA) 219661 | 001 | METHENAMINE HIPPURATE | METHENAMINE HIPPURATE | 马尿酸乌洛托品 | TABLET;ORAL | 1GM | ZYDUS LIFESCIENCES | 2025-03-10 | No | No | RX | AB |
(ANDA) 206183 | 002 | PRALATREXATE | PRALATREXATE | 普拉曲沙 | SOLUTION;INTRAVENOUS | 40MG/2ML (20MG/ML) | DR REDDYS | 2025-03-10 | No | No | RX | AP |
(ANDA) 208662 | 002 | TAZAROTENE | TAZAROTENE | 他扎罗汀 | CREAM;TOPICAL | 0.05% | COSETTE | 2025-03-10 | No | No | RX | AB |
(ANDA) 206183 | 001 | PRALATREXATE | PRALATREXATE | 普拉曲沙 | SOLUTION;INTRAVENOUS | 20MG/ML (20MG/ML) | DR REDDYS | 2025-03-10 | No | No | RX | AP |
(ANDA) 218559 | 001 | KETOCONAZOLE | KETOCONAZOLE | 酮康唑 | SHAMPOO;TOPICAL | 2% | ZYDUS LIFESCIENCES | 2025-03-07 | No | No | RX | AB |
(ANDA) 218555 | 001 | ARFORMOTEROL TARTRATE | ARFORMOTEROL TARTRATE | 酒石酸阿福特罗 | SOLUTION;INHALATION | EQ 0.015MG BASE/2ML | MICRO LABS | 2025-03-07 | No | No | RX | AN |
(ANDA) 202954 | 001 | SILDENAFIL CITRATE | SILDENAFIL CITRATE | 枸橼酸西地那非 | TABLET;ORAL | EQ 20MG BASE | JUBILANT GENERICS | 2025-03-06 | No | No | RX | AB |
(ANDA) 216729 | 003 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 左甲状腺素钠 | POWDER;INTRAVENOUS | 500MCG/VIAL | STERISCIENCE | 2025-03-05 | No | No | RX | AP |
(ANDA) 212652 | 001 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | 艾司奥美拉唑镁 | FOR SUSPENSION, DELAYED RELEASE;ORAL | EQ 10MG BASE/PACKET | TORRENT | 2025-03-05 | No | No | RX | AB |
(ANDA) 216729 | 001 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 左甲状腺素钠 | POWDER;INTRAVENOUS | 100MCG/VIAL | STERISCIENCE | 2025-03-05 | No | No | RX | AP |
(ANDA) 212651 | 002 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | 艾司奥美拉唑镁 | FOR SUSPENSION, DELAYED RELEASE;ORAL | EQ 5MG BASE/PACKET | TORRENT | 2025-03-05 | No | No | RX | AB |
(ANDA) 216729 | 002 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 左甲状腺素钠 | POWDER;INTRAVENOUS | 200MCG/VIAL | STERISCIENCE | 2025-03-05 | No | No | RX | AP |